PHOTODYNAMIC BONE STABILIZATION SYSTEM

Description of Event or Problem

A PELVIS CASE WAS PERFORMED THE USER HAD IMPLANTED AN 8 X 100 MM BALLOON AND WAS TRYING TO SEPARATE THE CATHETER FROM THE IMPLANT. THEY USED THE SMALL SCORING TUBE AND WHEN TRYING TO SEPARATE, ONLY ABOUT 3.5 INCHES OF THE CATHETER BROKE OFF, AND THE REST REMAINED ATTACHED TO THE IMPLANT. WHEN PULLED THE SCORING TUBE BACK OUT OF THE INCISION, THE SCORING TUBE HAD BROKEN IN HALF. THE USER HAD TO RETRIEVE THE BROKEN PIECE OF THE SCORING TUBE FROM THE INCISION AND USE A NEW SCORING TUBE. THEY WERE UNABLE TO SEPARATE THE REST OF THE CATHETER USING THE ILLUMINOSS SEPARATOR INSTRUMENTS, SO THE USER HAD TO WIDEN THE INCISION AND USE RONGEURS TO CUT THE REST OF THE CATHETER OFF. OTHER BALLOONS WERE USED IN THE CASE WHERE THE DEEP TISSUE SCORER WAS USED TO SEPARATE THE CATHETER AND IT WORKED FINE. THERE WAS A 15 MINUTE DELAY DUE TO THE DIFFICULTIES REMOVING THE CATHETER.

Additional Manufacturer Narrative

THE INVESTIGATION HAS DETERMINED THAT A POTENTIAL CAUSE FOR ONLY A PORTION OF THE CATHETER INITIALLY BEING ABLE TO BE REMOVED FROM THE IMPLANT WHEN USING THE SCORING TUBE IS DUE TO THE USER NOT HAVING THE SCORING TUBE FAR ENOUGH DOWN THE CATHETER SUCH THAT THE SERRATED EDGE TOUCHES AND IS ALIGNED WITH THE IMPLANT. IF THE SCORING TUBE WAS INADVERTENTLY NOT TOUCHING THE IMPLANT WHEN ROTATED TO SCORE THE IMPLANT, THE USER COULD HAVE INADVERTENTLY SCORED THE CATHETER TUBE INSTEAD OF THE IMPLANT, RESULTING IN ONLY A PORTION OF THE CATHETER BEING INITIALLY REMOVED BECAUSE THE CATHETER WAS SCORED ALONG ITS LENGTH INSTEAD OF AT THE IMPLANT. IFU 900356 STATES THAT RISKS INCLUDE INABILITY TO PROPERLY DEPLOY OR REMOVE DEVICE. THE IFU ALSO STATES TO ENSURE THE SEPARATION INSTRUMENT CAN REACH THE BALLOON. THE STG FOR PELVIS 900598_A ALSO INCLUDES INSTRUCTIONS FOR THE SEPARATION OF CATHETER. THE STG STATES TO ENSURE THE SERRATED END OF THE INSTRUMENT EITHER TOUCHES AND ALIGNS CLOSELY WITH THE PROXIMAL END OF THE IMPLANT AND THAT SEVERAL CENTIMETERS OF THE CATHETER SHOULD PROTRUDE OUT FROM THE KNOB OF THE INSTRUMENT. THE THE SCORING TUBE WAS DISCARDED IN THE OR AND THEREFORE COULD NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

THIS FOLLOW-UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION WITH ADDITIONAL FINDINGS AND A CONCLUSION, INVESTIGATION TYPE, INVESTIGATION FINDINGS AND INVESTIGATION CODE. THE INVESTIGATION HAS DETERMINED THAT A POTENTIAL CAUSE FOR ONLY A PORTION OF THE CATHETER INITIALLY BEING ABLE TO BE REMOVED FROM THE IMPLANT WHEN USING THE SCORING TUBE IS DUE TO THE USER NOT HAVING THE SCORING TUBE FAR ENOUGH DOWN THE CATHETER SUCH THAT THE SERRATED EDGE TOUCHES AND IS ALIGNED WITH THE IMPLANT. IF THE SCORING TUBE WAS INADVERTENTLY NOT TOUCHING THE IMPLANT WHEN ROTATED TO SCORE THE IMPLANT, THE USER COULD HAVE INADVERTENTLY SCORED THE CATHETER TUBE INSTEAD OF THE IMPLANT, RESULTING IN ONLY A PORTION OF THE CATHETER BEING INITIALLY REMOVED BECAUSE THE CATHETER WAS SCORED ALONG ITS LENGTH INSTEAD OF AT THE IMPLANT. IFU 900356 STATES THAT RISKS INCLUDE INABILITY TO PROPERLY DEPLOY OR REMOVE THE DEVICE. THE IFU ALSO STATES TO ENSURE THE SEPARATION INSTRUMENT CAN REACH THE BALLOON. THE STG FOR PELVIS 900598_A ALSO INCLUDES INSTRUCTIONS FOR THE SEPARATION OF CATHETER. THE STG STATES TO ENSURE THE SERRATED END OF THE INSTRUMENT EITHER TOUCHES AND ALIGNS CLOSELY WITH THE PROXIMAL END OF THE IMPLANT AND THAT SEVERAL CENTIMETERS OF THE CATHETER SHOULD PROTRUDE OUT FROM THE KNOB OF THE INSTRUMENT. POTENTIAL FOR USER ERROR THE DISTRIBUTOR WHO REPORTED THE COMPLAINT STATED THAT THERE WAS NO EXCESSIVE FORCE USED ON THE SMALL SCORING TUBE THAT BROKE AND THE CATHETER WAS ATTEMPTED TO BE SEPARATED PER THE INSTRUCTIONS FOR USE. THE USER IS AN EXPERIENCED ILLUMINOSS USER AND WAS ABLE TO SUCCESSFULLY SEPARATE OTHER IMPLANTS DURING THE CASE USING THE DEEP TISSUE SCORER. WHILE THERE IS NO INDICATION THAT USER ERROR CONTRIBUTED TO THIS COMPLAINT, THERE ARE SEVERAL POTENTIAL CAUSES OF THE DIFFICULTY AND INCOMPLETE SEPARATION OF THE CATHETER DUE TO USER ERROR WHICH COULD NOT BE RULED OUT BALLOON PLACED TOO FAR AWAY FROM ACCESS SITE, IMPROPER BALLOON SIZING. OFF-LABEL USE: ACCESS PORTAL DRILLED/CREATED AT HIGH ENTRY ANGLE (UNABLE TO ACHIEVE LOW ENTRY ANGLE). OFF-LABEL USE: USER KINKED FLOW TUBE WHICH PREVENTS FLEX TUBE STABILIZER FROM INSERTION OVER IT. UNINTENTIONAL MISUSE: INADEQUATE SERRATED END OF STABILIZER. CATHETER (FLOW TUBE PORTION) WAS KINKED OR PINCHED DURING CURE CYCLE RESULTING IN OUT-OF-ROUND SHAPE THAT PREVENTS STABILIZER FLEX TUBE FROM ADVANCING OVER IT. INADEQUATE LOCKING FEATURE DAMAGES FLOW TUBE AT GRIP PORTION (SEPARATOR CAUSES FLOW TUBE TO BREAK AT GRIP POINT INSTEAD OF JUST HOLDING TO SEPARATE AT THE IMPLANT). THE CAUSE OF THE DIFFICULTY AND INCOMPLETE SEPARATION OF THE CATHETER WAS ABLE TO BE NARROWED DOWN TO SIX POTENTIAL CAUSES WITH THE INFORMATION AVAILABLE IN THE COMPLAINT. NO DEFINITIVE CAUSE COULD BE IDENTIFIED WITH THE INFORMATION AVAILABLE AS THERE WERE NO X-RAYS PROVIDED, AND THE SEPARATOR AND CATHETER PORTIONS WERE DISCARDED IN THE OR AND NOT RETURNED FOR EVALUATION. THE CAUSE OF THE BROKEN SMALL SCORING TUBE IS UNKNOWN BUT COULD BE DUE TO THE SCORING TUBE BEING DAMAGED FROM PREVIOUS USE WHICH WAS NOT IDENTIFIED PRIOR TO USE BUT AS NO DAMAGE WAS REPORTED ON THE SCORING TUBE BEFORE USE, THIS CANNOT BE CONFIRMED. CONCLUSION: THE CAUSE OF THE DIFFICULTY EXPERIENCED ATTEMPTING TO SEPARATE THE CATHETER FROM THE BALLOON, INCOMPLETE INITIAL SEPARATION OF THE CATHETER, AND BROKEN SMALL SCORING TUBE ARE UNKNOWN.

Description of Event or Problem

A PELVIS CASE WAS PERFORMED THE USER HAD IMPLANTED AN 8X100MM BALLOON AND WAS TRYING TO SEPARATE THE CATHETER FROM THE IMPLANT. THEY USED THE SMALL SCORING TUBE AND WHEN TRYING TO SEPARATE, ONLY ABOUT 3.5 INCHES OF THE CATHETER BROKE OFF, AND THE REST REMAINED ATTACHED TO THE IMPLANT. WHEN PULLED THE SCORING TUBE BACK OUT OF THE INCISION, THE SCORING TUBE HAD BROKEN IN HALF. THE USER HAD TO RETRIEVE THE BROKEN PIECE OF THE SCORING TUBE FROM THE INCISION AND USE A NEW SCORING TUBE. THEY WERE UNABLE TO SEPARATE THE REST OF THE CATHETER USING THE ILLUMINOSS SEPARATOR INSTRUMENTS, SO THE USER HAD TO WIDEN THE INCISION AND USE RONGEURS TO CUT THE REST OF THE CATHETER OFF. OTHER BALLOONS WERE USED IN THE CASE WHERE THE DEEP TISSUE SCORER WAS USED TO SEPARATE THE CATHETER AND IT WORKED FINE. THERE WAS A 15 MINUTE DELAY DUE TO THE DIFFICULTIES REMOVING THE CATHETER.